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Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE).
Fam Pract. 2012 Oct; 29(5):521-7.FP

Abstract

BACKGROUND

Rimonabant treatment, examined in Phase 3 trials, showed improvement of cardiovascular risk factors in obese patients.

OBJECTIVE

The objective of this Phase 4 trial is to assess the effectiveness of rimonabant plus lifestyle counselling when used in daily practice, namely in the general practice. The hypothesis was that the effectiveness in Phase 4 would be smaller than the efficacy in Phase 3 due to different patient selection and treatment conditions. At the end of this trial, rimonabant was suspended of all markets due to psychiatric side effects.

METHODS

This trial randomly assigned 222 patients with enlarged waist circumferences and hyperglycaemia or diabetes mellitus type 2, recruited from Dutch general practices, to double-blinded therapy with either placebo or rimonabant (20 mg/day) for 1 year in addition to lifestyle counselling.

RESULTS

Compared with placebo, the rimonabant group showed significant improvements in body weight, body mass index, high-density lipoprotein (HDL) cholesterol and the main outcome waist circumference after 1 year. The United Kingdom Prospective Diabetes Study risk calculation showed no significant difference. The rimonabant group showed statistically deterioration, compared with the placebo group, in the quality of life in the EuroQol and two domains of the SF-36: role limitations due to physical health problems and bodily pain.

CONCLUSIONS

The unique real life data of this Phase 4 trial showed that the effectiveness of rimonabant in daily practice is indeed lower than in controlled circumstances (Phase 3). Rimonabant treatment showed improvement of obesity and the HDL cholesterol, but had no positive effect on the other cardiovascular risk factors and the quality of life.

Authors+Show Affiliations

Department of General Practice, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre, Maastricht, The Netherlands. jolienboesten@hag.unimaas.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22389428

Citation

Boesten, Jolien E J., et al. "Rimonabant Improves Obesity but Not the Overall Cardiovascular Risk and Quality of Life; Results From CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn By Rimonabant: the Effectiveness in Daily Practice and Its USE)." Family Practice, vol. 29, no. 5, 2012, pp. 521-7.
Boesten JE, Kaper J, Stoffers HE, et al. Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE). Fam Pract. 2012;29(5):521-7.
Boesten, J. E., Kaper, J., Stoffers, H. E., Kroon, A. A., & van Schayck, O. C. (2012). Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE). Family Practice, 29(5), 521-7.
Boesten JE, et al. Rimonabant Improves Obesity but Not the Overall Cardiovascular Risk and Quality of Life; Results From CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn By Rimonabant: the Effectiveness in Daily Practice and Its USE). Fam Pract. 2012;29(5):521-7. PubMed PMID: 22389428.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE). AU - Boesten,Jolien E J, AU - Kaper,Janneke, AU - Stoffers,Henri E J H, AU - Kroon,Abraham A, AU - van Schayck,Onno C P, Y1 - 2012/03/01/ PY - 2012/3/6/entrez PY - 2012/3/6/pubmed PY - 2013/2/14/medline SP - 521 EP - 7 JF - Family practice JO - Fam Pract VL - 29 IS - 5 N2 - BACKGROUND: Rimonabant treatment, examined in Phase 3 trials, showed improvement of cardiovascular risk factors in obese patients. OBJECTIVE: The objective of this Phase 4 trial is to assess the effectiveness of rimonabant plus lifestyle counselling when used in daily practice, namely in the general practice. The hypothesis was that the effectiveness in Phase 4 would be smaller than the efficacy in Phase 3 due to different patient selection and treatment conditions. At the end of this trial, rimonabant was suspended of all markets due to psychiatric side effects. METHODS: This trial randomly assigned 222 patients with enlarged waist circumferences and hyperglycaemia or diabetes mellitus type 2, recruited from Dutch general practices, to double-blinded therapy with either placebo or rimonabant (20 mg/day) for 1 year in addition to lifestyle counselling. RESULTS: Compared with placebo, the rimonabant group showed significant improvements in body weight, body mass index, high-density lipoprotein (HDL) cholesterol and the main outcome waist circumference after 1 year. The United Kingdom Prospective Diabetes Study risk calculation showed no significant difference. The rimonabant group showed statistically deterioration, compared with the placebo group, in the quality of life in the EuroQol and two domains of the SF-36: role limitations due to physical health problems and bodily pain. CONCLUSIONS: The unique real life data of this Phase 4 trial showed that the effectiveness of rimonabant in daily practice is indeed lower than in controlled circumstances (Phase 3). Rimonabant treatment showed improvement of obesity and the HDL cholesterol, but had no positive effect on the other cardiovascular risk factors and the quality of life. SN - 1460-2229 UR - https://www.unboundmedicine.com/medline/citation/22389428/Rimonabant_improves_obesity_but_not_the_overall_cardiovascular_risk_and_quality_of_life L2 - https://academic.oup.com/fampra/article-lookup/doi/10.1093/fampra/cms013 DB - PRIME DP - Unbound Medicine ER -